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Completed

NCT Number: NCT04013841

Bowel Preparation Impact on the Intestinal Microbiome: Oral Preparation vs Enema

Mechanical bowel preparation for left-sided colorectal surgery remains standard in most cases. However, there are some discrepancies on how to prepare the bowl, while rectal enema and oral agents are both available methods.

The knowledge of intestinal microbiome role on surgical outcomes is increasing, since few recent reports linked microbiome composition to postoperative complications, such as anastomotic insufficiency. Although, it is not clear how the bowel preparation affects the gut microbiome. Therefore, different bowel preparation techniques impact on gut microbiome will be studied.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Institute

Vilnius, Lithuania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 y.;
  • Signed informed consent;
  • Left-side colorectal resection for colorectal cancer;

Exclusion criteria

  • Anticipated ileostoma;
  • Allergy to oral preparation agents;
  • Multivisceral surgery;
  • Emergency surgery;
  • History of inflammatory bowel disease;
  • History of surgery disrupting gastrointestinal tract integrity;
  • Signs of tumor obturating the lumen of the bowel;
  • Pregnancy;

Treatment and study plan

Oral-agents/Enema

Other
  • Oral-agents for mechanical bowel preparation prior to left-side colorectal resection
  • Enema for mechanical bowel preparation prior to left-side colorectal resection

Primary outcomes

  1. Intestinal microbiome composition

    Time frame: 6 days after surgery

    Significant differences in the beta-diversity of the intestinal microbiome between oral and enema groups

Secondary outcomes

  1. Intestinal microbiome composition

    Time frame: 30 days after surgery

    Significant differences in the beta-diversity of the intestinal microbiome between oral and enema groups

  2. Intestinal microbiome composition

    Time frame: 6 and 30 days after surgery

    Significant differences in the alpha-diversity of the intestinal microbiome between oral and enema groups

Sponsors and collaborators

Lead sponsor

Vilnius University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Bowel Preparation for Left Side Colon Surgery Impact on the Intestinal Microbiome: Oral Preparation vs Enema

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 10, 2019
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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